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| |  Agomelatine Appears Superior to Sertraline for Treatment of Major Depressive Disorder: Presented at ECNP By Judith Moser, MD BARCELONA, Spain -- September 2, 2008 -- Agomelatine improves outcomes more effectively than sertraline in patients with major depressive disorder, according to the results of a randomised, double-blind study presented at 21st European College of Neuropsychopharmacology Congress (ECNP). Agomelatine, the first melatonergic antidepressant, has demonstrated efficacy in several clinical trials. The international, randomised, double-blind study presented by Siegfried Kasper, MD, Department of Psychiatry and Psychotherapy, Medical University, Vienna, Austria, tested agomelatine against the established antidepressant sertraline. "Compared to the older antidepressants, agomelatine offers the advantage of sleep induction," Dr. Kasper explained at a poster presentation on September 1. "With sleep induction, a faster onset of action occurs." Patients fulfilling Diagnostic and Statistical Manual, 4th Edition, criteria for major depressive disorder were randomised to receive either agomelatine 25 to 50 mg QD (n = 154) or sertraline 50 to 100 mg QD (n = 159). The efficacy of the treatment was assessed by means of the Hamilton Depression Rating Scale (HAM-D) 17-item final score and the Hamilton Anxiety Rating Scale (HAM-A) score. A response was defined as a decrease of at least 50% from baseline in the HAM-D total score. "We found a more rapid response in the patients treated with agomelatine within the first week," Dr. Kasper reported. At the end of the first week, a significant difference compared with sertraline in favour of agomelatine on the rest-activity rhythm parameter could be seen. In the second week of treatment, a mean decrease in the HAM-D total score from baseline was observed in both groups (from 26.1 to 18.9 in the agomelatine group and from 26.5 to 20.3 in the sertraline group). Dr. Kasper noted that results after 6 weeks of treatment indicated a better outcome with agomelatine treatment. At that time, a statistical significant superiority of agomelatine compared with sertraline was shown in mean decrease of the HAM-D total score (P = .031). The rate of responders was higher for agomelatine than for sertraline as soon as week 2 (20.0% vs 10.9%; P = .027). After 6 weeks of treatment, the respective numbers had increased to 70.0% and 61.5%, respectively (P = .119). In addition to its superior antidepressant effects, agomelatine demonstrated a better effect on anxiety symptoms after 6 weeks of treatment, with a difference of 2.34 in the HAM-A total score (P = .017). Adverse events leading to discontinuation were more frequent in the sertraline group than in the agomelatine group (11.3% vs 2.6%). "Agomelatine is a promising therapeutic agent for the treatment of major depressive disorder," Dr. Kasper concluded. Funding for this study was provided by Servier.
[Presentation title: Superior Antidepressant Efficacy of Agomelatine vs Sertraline: A Randomized, Double-Blind Study. Abstract P2c022]
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